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Trial record 8 of 73 for:    Tricuspid Regurgitation

Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND) (TriBAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779490
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

Condition or disease Intervention/treatment
Tricuspid Regurgitation Tricuspid Insufficiency Device: Transcatheter Tricuspid Valve Repair

Detailed Description:
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcatheter Repair of Tricuspid Regurgitation With Cardioband TR System Post-Market Clinical Follow-Up Study (TriBAND): A European Prospective, Multicenter Post-market Clinical Follow-up Study to Assess Transcatheter Tricuspid Valve Repair With Edwards Cardioband TR System in Patients With Symptomatic Chronic Functional Tricuspid Regurgitation.
Actual Study Start Date : July 24, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2026

Intervention Details:
  • Device: Transcatheter Tricuspid Valve Repair
    Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR


Primary Outcome Measures :
  1. Procedure Success [ Time Frame: Hospital discharge, 2-7 days post-procedure ]
    Reduction in severity of Tricuspid Regurgitation at discharge.


Secondary Outcome Measures :
  1. Major Adverse Event Rate [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Rates of major adverse

  2. Procedure Success [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Reduction in severity of Tricuspid Regurgitation (TR) severity

  3. Change in Quality of Life - KCCQ [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Improvement in Quality of Life as assessed by KCCQ.

  4. Change in Quality of Life - EQ-5D-5L [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Improvement in Quality of Life as assessed by EQ-5D-5L



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Symptomatic patients with chronic functional tricuspid regurgitation (FTR)
Criteria
  • Inclusion Criteria:

    • Eighteen (18) years of age or older
    • Moderate or greater functional Tricuspid Regurgitation (TR)
    • Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use.
  • Exclusion Criteria:

    • Patients deemed anatomically unsuitable for the device by echocardiography
    • Patients in whom transesophageal echocardiography (TEE) is contraindicated
    • Previous tricuspid valve repair or replacement
    • Severe aortic, mitral and / or pulmonic valve stenosis
    • Severe aortic, mitral and / or pulmonic valve regurgitation
    • Renal Insufficiency requiring dialysis or severe kidney renal disease
    • Life expectancy of less than twelve months
    • Patient is pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779490


Contacts
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Contact: TMTT Clinical Affairs +1 (949) 250-2500 TMTT_Clinical@edwards.com

Locations
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Germany
Universitätsklinik der Ruhr-Universität Bochum Recruiting
Bad Oeynhausen, North Rhine Westphalia, Germany, 32545
Contact: Kai Friedrichs, MD    +49 5731 973 667    kpfriedrichs@hdz-nrw.de   
Principal Investigator: Kai Friedrichs, MD         
Herzzentrum der UniKlinik Köln Recruiting
Cologne, NRW, Germany, 50924
Contact: Stephan Baldus, MD       stephan.baldus@uk-koeln.de   
St. - Johannes-Hospital Recruiting
Dortmund, NRW, Germany, 44137
Contact: Helge Möllmann, MD    +49231 1843 ext 35111    helge.moellmann@joho-dortmund.de   
Berlin Charité-Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Alexander Lauten    +49 30 450 513 736    alexander.lauten@charite.de   
Principal Investigator: Alexander Lauten         
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 51312
Contact: Georg Nickenig    +49 228 287 15259    georg.nickenig@ukb.uni-bonn.de   
Principal Investigator: Georg Nickenig         
Herzzentrum Universitätsklinik Dresden Recruiting
Dresden, Germany, 01307
Contact: Axel Linke    +49 351 450 1710    axel.linke@herzzentrum-dresden.com   
Principal Investigator: Axel Linke         
University Hospital Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Martin Arnold    0049 9131 853 5301    martin.arnold@uk-erlangen.de   
Principal Investigator: Martin Arnold         
Universitätsmedizin Göttingen, Herzzentrum Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Claudius Jacobshagen, MD       jacobshagen@med.uni-goettingen.de   
Asklepios Klinik St. Gerorg Recruiting
Hamburg, Germany, 20099
Contact: Felix Meincke, MD       f.meincke@asklepios.com   
Katholisches Marienkrankenhaus Recruiting
Hamburg, Germany, 22087
Contact: Ulrich Schäfer, MD    +49 40 2546 ext 2102    schaefer.kardiologie@marienkrankenhaus.org   
Universitätsmedizin der Johannes Gutenberg Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: Stephan Von Bardeleben    +49 6131 172892    stephan.von_Bardeleben@unimedizin-mainz.de   
Principal Investigator: Stephan Von Bardeleben         
Switzerland
Universitätsspital Bern (Inselspital) Not yet recruiting
Bern, Switzerland, 3010
Contact: Stephan Windecker, MD    +41 31 632 44 97    stephan.windecker@insel.ch   
Principal Investigator: Stephan Windecker, MD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Georg Nickenig, MD Universitätsklinikum Bonn, Germany
Principal Investigator: Stephan Windecker, MD Inselspital Bern, Switzerland
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03779490    
Other Study ID Numbers: 2017-21
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Edwards Lifesciences:
Edwards Cardioband TR
Annuloplasty
Tricuspid Repair
Tricuspid Valve
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases